In the field of diagnosis and therapy of vascular, cardiac, oncological and other diseases, non-surgical methods are used more and more. The principal uses in the scope of these methods are those which use a catheter introduced intraluminally into vessels, particularly arteries. In accordance with the reasons for the introduction of catheters, catheters of different external diameters are used. The unit generally used to identify the diameter is called "French". One French is about 0.3 mm. The most commonly used catheters are in the range of 6 to 8 Frenches. In recent times, a quite short external catheter called "sheet" has also been used more and more. A sheet is basically a synthetic tube 10 to 15 cm long, and its internal diameter is equal to the external diameter of the catheter used. The wall of a "sheet" is very thin, about 0.1 mm. The procedure is such that after the puncture of an artery, or possibly another vessel, by a thin needle a wire guide is introduced through this thin needle, and the needle is then removed. Using the wire-guide as the leader, a catheter, or possibly a catheter with a sheet, is introduced into a vessel.
After the diagnostic or therapeutic procedure is finished, the catheter is removed, but an interstice of proportionate dimension remains in the wall of the vessel. In point of fact, in 90% of cases when an artery is punctured, significant bleeding through the interstice occurs due to arterial pressure. The spontaneous sealing of the interstice by a thrombus can generally be achieved by manually applying pressure to the vessel transcutaneously in the proper place for about 20 minutes. During the following 24 hours, the patient stays in a horizontal position and a bag filled with sand weighing about 2.0 kg is placed transcutaneously on the location of the puncture, mostly in the groin. This approach has, of course, quite a few disadvantages. At first, the patient has to lie in a horizontal position. This means that hospitalization is necessary for at least for one day. On the one hand, this increases demand for bed capacity, and on the other hand increases expense. Further, in some cases, even when using the above-described procedure, one of two complications can occur. One is that bleeding is not completely stopped or that bleeding resumes after some time. In this case, surgical intervention with direct suture of the interstice in the wall of the vessel is necessary. Less often, but not exceptionally, the manual compression is too effective and a thrombus develops to occlude not only the interstice in the wall of the vessel but also the lumen of the vessel with all associated consequences. In this case also surgical intervention is necessary. In both cases hospitalization is prolonged and expenses increase.
From the literature, two attempts for solution of this problem are presently known. Both reportedly are undergoing clinical examination. The first is known under the name "VASOSEAL". In accordance with a published description thereof, before puncture of an artery, the distance between the skin and the vessel is measured. When the procedure is finished and the catheter removed, then in accordance with the data on the measuring device, a special applicator is introduced into the wall of the vessel. By this applicator, collagen in an amorphous form (as illustrated) is applied to the interstice in the wall. Using the applicator, the collagen is compressed against the wall for five minutes to seal the interstice. The other approach is known under the name "Hemostatic Puncture Closing Device". According to the literature, the device comprises a polymer anchor, collagen plug and resorbable fiber. After removal of the catheter by a method which is not entirely clear from the description, the anchor with the fiber is introduced into the wall of the vessel so that the fiber fixes the collagen plug over the interstice.
The basic disadvantage of both approaches is that they can be employed only after the catheter or the sheet is removed. Bleeding appears immediately, and even in the case of very fast application, the development of certain hematoma cannot be prevented. This is in addition to the discomfort of working in the bleeding area. Another disadvantage is that the treated vessel cannot be used for another puncture for at least one month. The second approach described above is also complicated, and for proper execution, some special training is necessary, particularly for personnel without surgical training. Also, both devices are expensive, and particularly in countries with inferior levels of medical care, the cost for a device can be higher than the cost for one-day of hospitalization.